Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis
Secondary (AA) Amyloidosis, Rheumatoid Arthritis, Nephrotic Syndrome
About this trial
This is an interventional treatment trial for Secondary (AA) Amyloidosis focused on measuring Familial Mediterranean Fever, Amyloidosis, Secondary (AA) Amyloidosis, Nephrotic Syndrome
Eligibility Criteria
PROTOCOL INCLUSION CRITERIA Patients must be 18 years of age or older. Males and females. If women of childbearing potential (i.e., not surgically sterilized or post-menopausal greater than one year) the patient must be using effective birth control. Diagnosis of AA amyloidosis demonstrated by positive biopsy (Congo red staining) and immunohistochemistry or immunoelectron microscopy at screening visit. Tissue from previous biopsy can be used for confirmation of diagnosis, if available. Persistent proteinuria defined as urinary protein excretion ? 1g/24h in two distinct 24-h urine collections at least 1 week apart within 3 months prior to study entry (baseline, Month 0 visit) without evidence of urinary tract infection or overt heart failure (NYHA class III or more); OR creatinine clearance ? 60 mL/min in two distinct measures at least 1 week apart within 3 months prior to study entry (baseline, Month 0 visit). Creatinine clearance ? 20 mL/min AND serum creatinine ? 3 mg/dl within 3 months prior to study entry (baseline, Month 0 visit). Written informed consent. PROTOCOL EXCLUSION CRITERIA Evidence or suspicion of renal or renovascular diseases other than renal AA amyloidosis. Presence of diabetes mellitus (Type I and II). Evidence of a cause of potentially reversible reduced renal function, such as accelerated hypertension or drug nephrotoxicity. AST, ALT, or ALP > 5 times the upper limit of normal, or total bilirubin 50% above upper limits of normal. Presence of any other clinically significant diseases that could interfere with the interpretation of study results or compromise patient safety or any conditions that could reduce life expectancy to less than two years. Use of an investigational drug within thirty days prior to the screening visit. Active alcohol and/or drug abuse. Initiation of or any changes in ACE inhibitor therapy within 3 months prior to the screening visit. Initiation of or any changes in cytotoxic agents/colchicine therapy within 3 months prior to the screening visit. Inability to provide legal consent.
Sites / Locations
- Indiana University School of Medicine, Department of Pathology and Laboratory Medicine,
- Boston Medical Center, Renal Division
- Mayo Clinic
- Mount Sinai Medical Center
- Rheumatism Foundation Hospital
- Centre Hospitalier du Mans, Service de Rhumatologie
- Hôpital Claude Huriez, Service de médecine Interne, Clinique Médicale A
- Hôpital Cochin, Centre de Recherche et d'Explorations Fonctionnelles
- Bnai Zion Medical Center
- Heller Institute of Medical Research, Sheba Medical Center
- Italian Group for Systemic Amyloidosis, Biotechnology Research Laboratories, IRCCS Policlinico San Matteo, Internal Medicine and Medical Oncology
- Vilnius University Hospital
- University Hospital Groningen, Department of Medicine, Division of Rheumatology
- Instytut Reumatologiczny
- Okregowy Szpital Kolejowy, Zaklad Reumatologii
- Institute of Rheumatology RAMS
- Regional Hospital No. 1
- Hospital Universitario Germans Trias I Pujol, Servicio de Reumatologia
- Hospital Clinic I Provincial de Barcelona, Jefe del Departamento de Reumatologia
- Ciutad Sanitària y Universitària de Bellvitge, Servicio de Reumatologia, Hospitalet de Llobregat
- Hospital Clinico San Carlos de Madrid, Servicio de Reumatologia
- Cerrehpasa Tip Fakultesi
- Istanbul Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology
- Marmara University Medical School Hospital, Department of Rheumatology
- Royal Free and University College Medical School, Department of Medicine, National Amyloidosis Centre
- Gartnavel General Hospital